Hypercholesterolemia

FDA approval · 2022-11-02

FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

FDA approved a supplemental application for Colesevelam hydrochloride (generic) from Glenmark Pharmaceuticals Inc., USA.

FDA approval · 2022-10-13

FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

FDA approved Lupin Pharmaceuticals' supplemental ANDA for pravastatin sodium, enabling a generic version of pravastatin.

FDA approval · 2022-09-28

FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

FDA approved a supplemental application for Colesevelam hydrochloride (generic Colesevelam) from Glenmark Pharmaceuticals, authorizing its c…

FDA approval · 2022-08-29

FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)

FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…

CLINICAL_TRIALS withdrawal · 2022-07-28

Clinical Trial Update: Evolocumab In Advanced Chronic Kidney Disease Trial [Phase 4]

A Phase 4 trial of evolocumab in advanced chronic kidney disease has been withdrawn.

FDA approval · 2022-07-26

FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)

FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…

CLINICAL_TRIALS trial_result · 2022-07-20

Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A [Phase 3]

Phase 3 clinical trial evaluating the efficacy and safety of AD-221 and AD-221A for primary hypercholesterolemia has been completed.

CLINICAL_TRIALS trial_result · 2022-07-20

Clinical Trial Update: Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients [Phase 4]

Phase 4 trial assessing the effect of amlodipine on lipid profile in newly diagnosed hypertensive patients.

CLINICAL_TRIALS trial_result · 2022-07-15

Clinical Trial Update: Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients [Phase 2]

Phase 2 dose-ranging study evaluating intravenous atorvastatin in hypercholesterolemia; results have been posted after completion.

CLINICAL_TRIALS trial_result · 2022-07-14

Clinical Trial Update: Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product [Phase 3]

A completed Phase 3 cross-over trial comparing two production processes (Process 1 vs Process 2) of LIB003 to assess pharmacokinetics and ph…

FDA approval · 2022-07-08

FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

FDA approved the supplemental application for atorvastatin calcium from NIVAGEN Pharmaceuticals, Inc., authorizing the generic product.

CLINICAL_TRIALS trial_result · 2022-05-18

Clinical Trial Update: Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia [Phase 3]

Phase 3 trial comparing 1PC111 with pitavastatin and ezetimibe in primary hypercholesterolemia or mixed dyslipidemia completed.

CLINICAL_TRIALS trial_result · 2022-04-13

Clinical Trial Update: Supplementation of Oil Palm Phenolics to Improve Lipid Profile in Subjects With Minor Hyperlipidaemia [Phase 2]

Phase 2 trial evaluating supplementation of oil palm phenolics to improve lipid profiles in individuals with minor hyperlipidaemia/hyperchol…

CLINICAL_TRIALS trial_result · 2022-04-11

Clinical Trial Update: Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia [Phase 3]

Phase 3 trial update reporting safety and efficacy of IBI306 in Chinese subjects with non-familial hypercholesterolemia has completed.

CLINICAL_TRIALS trial_result · 2022-04-11

Clinical Trial Update: Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia [Phase 4]

Phase 4 trial comparing pitavastatin to atorvastatin for hypercholesterolemia completed.

CLINICAL_TRIALS trial_result · 2022-04-04

Clinical Trial Update: A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance [Phase 2]

Phase 2 study assessing ETC-1002 (bempedoic acid) for efficacy and safety in individuals with statin intolerance; completed with posted resu…

FDA approval · 2022-03-10

FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

FDA approves a generic version of Colestipol Hydrochloride under an Original Application filed by Zydus Lifesciences Limited.

FDA approval · 2022-03-03

FDA Approved: NIACIN — Original Application (Macleods Pharmaceuticals Limited)

FDA approved the original application for NIACIN (nicotinic acid) from Macleods Pharmaceuticals Limited, establishing a generic version of t…

CLINICAL_TRIALS trial_result · 2022-02-18

Clinical Trial Update: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151) [Phase 4]

Phase 4 trial evaluating the effect of coadministering ezetimibe with simvastatin in a Middle Eastern population for hypercholesterolemia.